BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1803276 · Received August 17, 2010

    Report

    Report Number
    2182208-2010-00588
    Event Type
    Injury
    Date Received
    August 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING FEELING. DEVICE WAS TESTED IN UNIPOLAR CONFIGURATION ON BOTH LEADS, WITH HIGH OUTPUTS ON BOTH LEADS, WITH PATIENT MOVEMENT, AND THE SYMPTOMS COULD NOT BE PRODUCED. THE DEVICE STATUS IS UNKNOWN. EFFORTS TO CONTACT THE PHYSICIAN/HOSPITAL REGARDING THIS EVENT ARE IN PROCESS AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention